Vimseltinib Medicine 03 December 2024 Extended indication First line treatment of tenosynovial giant cell tumour in adults and elderly who are not amenable to surgery, monotherapy. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Vimseltinib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication First line treatment of tenosynovial giant cell tumour in adults and elderly who are not amenable to surgery, monotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Deciphera Pharmaceuticals Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date July 2024 Expected Registration August 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Primary completion (actual): 10 augustus 2023. Deciphera heeft vimseltinib ingediend op 19 juli 2024. Uitgaande van gemiddelde doorlooptijden wordt een registratiedatum van augustus 2025 verwacht. Therapeutic value Current treatment options Synovectomie (verwijdering van het synoviale weefsel rond een gewricht). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Geen farmacotherapeutische opties naast synovectomie. Uit de motion studie bleek een significante respons van vimseltinib ten opzichte van placebo. Er zijn geen vergelijkende studies gedaan met andere opties zoals imatinib, nilotinib. Duration of treatment Frequency of administration 2 times a week Dosage per administration 30mg References NCT05059262 (MOTION) Additional remarks Expected patient volume per year Patient volume < 702 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Patiëntenfolder Tenosynoviale reusceltumor (TGCT). LUMC. 2024 (1). Additional remarks Tenosynoviale reusceltumor is een zeldzame ziekte. De lokale vorm komt het meest voor en per jaar krijgen ongeveer 39 op de miljoen mensen deze diagnose (1). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks